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Trial registered on ANZCTR


Registration number
ACTRN12624001083583
Ethics application status
Approved
Date submitted
25/07/2024
Date registered
6/09/2024
Date last updated
6/09/2024
Date data sharing statement initially provided
6/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Is the Rectus Sheath block effective as the sole anesthetic technique for inserting a peritoneal catheter in patients with renal failure?
Scientific title
Peritoneal catheter: The effectiveness of Rectus Abdominis Sheath block as the sole anesthetic technique in patients who will undergo open surgery for the placement of a peritoneal catheter
Secondary ID [1] 312586 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic kidney disease 334511 0
end-stage renal disease 334512 0
Condition category
Condition code
Anaesthesiology 331126 331126 0 0
Anaesthetics
Anaesthesiology 331127 331127 0 0
Pain management
Surgery 331128 331128 0 0
Surgical techniques
Renal and Urogenital 331333 331333 0 0
Kidney disease
Renal and Urogenital 331334 331334 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective study. The study will include thirty consecutive patients or the available number of patients meeting the inclusion criteria within a period of 2 years. The subjects are patients with end-stage renal disease, according to The American Society of Anesthesiologists Physical Status Classification System (ASA) classified as II, III, or IV, who will undergo open surgery for the placement of a peritoneal catheter. The Bilateral Rectus Abdominis Sheath (RAS) block will be used as the sole anesthetic technique, administered under ultrasound guidance in a standardized manner. In our hospital, the Bilateral Rectus Abdominis Sheath (RAS) block technique is routinely employed for all patients undergoing peritoneal catheter insertion. Therefore, its use will not be exclusive to participants in this study. It will be performed by an experienced anesthesiologist (defined as having more than 10 years of clinical practice experience). To perform the RAS block, the patient is in the supine position and the ultrasound probe is positioned in a transverse orientation above the umbilicus, approximately 1 cm from the midline. The needle is inserted in-plane in a mediolateral direction through the subcutaneous tissue to penetrate the anterior sheath of the rectus abdominis muscle. The needle is then advanced through the muscle until its tip reaches the posterior sheath. After negative aspiration, the correct needle placement for the RAS block is confirmed by hydrodistension of the space between the flat abdominal muscle and the posterior sheath of the rectus under direct ultrasound guidance. The procedure will be performed bilaterally. For the RAS block, 2.0 mg/kg of 0.5% levobupivacaine will be used. 15 mL on each side, totaling 30 ml. .Before the surgery, the effectiveness of the block will be assessed with a cold sensation test and a pinprick pain test at the incision site. Immediately prior to the skin incision, patients will be sedated with remimidazolam to achieve a targeted Richmond Agitation Sedation Scale (RASS) score of -2 to -3, ensuring appropriate sedation for the regional anesthesia. Sufentanil (total of 10 mcg) will be administered to address anticipated discomfort from touching deep structures not covered by the block. Pain levels will be monitored using The Numeric Pain Rating Scale (NPRS) during the procedure, and if the NPRS score is 4 or higher, the patient will be converted to general anesthesia. A successful block will be indicated by not needing to switch to general anesthesia and no requirement for additional local anesthesia by the surgeon. Duration of the surgery is up to 1 hour. The recorded demographic data will include: age, sex, height, and weight. The recorded clinical data will include: ASA status, amount and dose of local anesthetic (LA), additional LA administered by the surgeon, conversion to general anesthesia, and NPRS scale immediately after the incision during the placement of the peritoneal catheter, and after the surgery at 1 and 6 hours after surgery, both at rest and during movement. Additionally, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) will be recorded every 5 minutes, along with the need and dose of additional opioid analgesia, sedation level according to the RASS, and the need and dose of postoperative analgesia based on the NPRS. Also, every strategy used to assess adherence to the intervention will be recorded by the anesthesiologist. Complications arising from the block will also be recorded, including vascular puncture, damage to abdominal structures, hypotension, intravascular injection of LA or signs of local anesthetic systemic toxicity (LAST), and the percentage of failed blocks that required conversion to other types of anesthesia. Also, surgical complications will be recorded. At least once every month in a period of one year after the placement of the catheter, catheter function will be recorded, and complications like: catheter infection, primary and secondary peritonitis and mechanical complications (bleeding, "leak," catheter migration) will be noted.






Intervention code [1] 329104 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338882 0
Success of the RAS block
Timepoint [1] 338882 0
NPRS scale immediately after the incision and during the placement of the peritoneal catheter.
Primary outcome [2] 338883 0
Surgical complications
Timepoint [2] 338883 0
Every month for the period of one year after the placement of the catheter or earlier in a case of emergency.
Secondary outcome [1] 437784 0
Duration of block
Timepoint [1] 437784 0
NPRS scale after the surgery at 1 and 6 hours, both at rest and during movement.
Secondary outcome [2] 437785 0
Hemodynamics
Timepoint [2] 437785 0
HR will be measured by standard ECG monitor every 5 minutes during the operation
Secondary outcome [3] 437786 0
Sedation
Timepoint [3] 437786 0
Every 5 minutes during the procedure
Secondary outcome [4] 437787 0
Pain management: Need and dose of additional opioid analgesia during surgery and need and dose of postoperative analgesia based on the NPRS.
Timepoint [4] 437787 0
NPRS scale during the surgery and after at 1 and 6 hours, both at rest and during movement.
Secondary outcome [5] 437788 0
Side-effects
Timepoint [5] 437788 0
The potential side effects mentioned will be noted immediately after performing the block and 1 and 6 hours after the surgery and recorded in patients medical records
Secondary outcome [6] 438532 0
Hemodynamics
Timepoint [6] 438532 0
SBP will be measured using an automated digital blood pressure monitor at 5-minute intervals throughout the duration of the surgery.
Secondary outcome [7] 438533 0
Hemodynamics
Timepoint [7] 438533 0
DBP will be measured using an automated digital blood pressure monitor at 5-minute intervals throughout the duration of the surgery.

Eligibility
Key inclusion criteria
The participants are patients who will undergo open surgery for the placement of a peritoneal catheter because of end-stage renal disease. ASA grade 2, 3 and 4. Age 18 years and over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients refusal, age under 18 years, infection at the injection site, severe coagulopathy, and allergy to local anesthetic.

Study design
Purpose
Duration
Longitudinal
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26444 0
Croatia
State/province [1] 26444 0
Zagreb

Funding & Sponsors
Funding source category [1] 317017 0
Hospital
Name [1] 317017 0
University Hospital Center Sestre milosrdnice
Country [1] 317017 0
Croatia
Primary sponsor type
Hospital
Name
University Hospital Center Sestre milosrdnice
Address
Country
Croatia
Secondary sponsor category [1] 319262 0
None
Name [1] 319262 0
Address [1] 319262 0
Country [1] 319262 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315773 0
ETICKO POVJERENSTVO KILINICKOG BOLNICKOG CENTRA SESTRE MILOSRDNICE
Ethics committee address [1] 315773 0
UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb, Croatia
Ethics committee country [1] 315773 0
Croatia
Date submitted for ethics approval [1] 315773 0
01/07/2024
Approval date [1] 315773 0
09/07/2024
Ethics approval number [1] 315773 0

Summary
Brief summary
The primary objective of our study is to determine whether the Rectus Abdominis Sheath (RAS) block can be used as a standalone anesthetic method for the placement of a peritoneal catheter using an open surgical technique. Open surgical technique is safe with minimal surgical or infectious complications. Research Hypothesis is that RAS block can be used as a standalone anesthetic method for the placement of a peritoneal catheter. Also, open surgical technique is safe method of choice for peritoneal catheter placement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135750 0
Dr Tomislav Radocaj
Address 135750 0
UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb
Country 135750 0
Croatia
Phone 135750 0
+385911262586
Fax 135750 0
Email 135750 0
[email protected]
Contact person for public queries
Name 135751 0
Tomislav Radocaj
Address 135751 0
UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb
Country 135751 0
Croatia
Phone 135751 0
+385911262586
Fax 135751 0
Email 135751 0
[email protected]
Contact person for scientific queries
Name 135752 0
Tomislav Radocaj
Address 135752 0
UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb
Country 135752 0
Croatia
Phone 135752 0
+385911262586
Fax 135752 0
Email 135752 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24040Ethical approval    388173-(Uploaded-23-07-2024-03-57-44)-Image_001.pdf



Results publications and other study-related documents

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